A Robot-assisted Tailored Activity Programme for People With Dementia and Their Caregivers

NCT07239869 | Recruiting Phase 1

• 1 other identifier: P0044775
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

To assess the feasibility and preliminary efficacy of the tailored activity programme on improving the physical inactivity of the caregiving dyads.

Conditions

Dementia; Caregiver; Physical Activity; Psychological Well Being

Outcome Measures

Primary Outcomes (1)

• Changes in physical activity

  Physical activity will be measured with the Chinese version of the International Physical Activity Questionnaire short version (IPAQ-C, short). The IPAQ-C is a 9-item instrument with good reliability and validity. Objective mesures will include number of steps, movement distance, sedentary minutes, inactive minutes collected with an activity tracker.

  Pre-intervention and immediately post-intervention

Secondary Outcomes (4)

• Changes in self-efficacy in physical activity

  Pre-intervention and immediately post-intervention

• Changes in quality of life

  Pre-intervention and immediately post-intervention

• Changes in neuropsychiatric symptoms of people with dementia

  Pre-intervention and immediately post-intervention

• Changes in psychological well-being

  Pre-intervention and immediately post-intervention

Study Arms (2)

Intervention

EXPERIMENTAL

Tweleve weeks of robot-assisted tailored activity programme

Other: Intervention

Control

OTHER

Usual care provided by community centers

Other: Control

Interventions

Intervention OTHER

12 weeks of robot assisted tailored activity programme

Intervention

Control OTHER

Usual care provided by community centers

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• mild to moderate stage dementia at a standardized mini-mental state examination score (MMSE) higher than 10;
• be able to walk independently;
• being physically inactive (categorized as "low/inactive" by the International Physical Activity Questionnaire);
• free from other medical/functional conditions that would limit physical activity.

You may not qualify if:

• high risk of falling (Berg Balance Scale \<45);
• not be suitable for doing physical activity as recommended by the primary care physician;
• currently involved in another interventional study involving physical exercise;
• had acute hospitalization \>3 times in the past year.
• primary informal caregivers who reside with the of the person with dementia;
• have provided care for more than six months;
• have no intention to send the care recipient to nursing homes in the next six months;
• being physically inactive;
• use a smartphone.
• caregivers with unstable physical or mental conditions;
• cannot communicate logically;
• not suitable for doing physical activity as recommended by a primary care physician.

Sponsors & Collaborators

• The Hong Kong Polytechnic University: lead

Study Sites (1)

The Hong Kong Polytechnic University

Hong Kong, Hong Kong

RECRUITING

MeSH Terms

Conditions

Dementia; Motor Activity; Psychological Well-Being

Interventions

Methods

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Behavior; Personal Satisfaction

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 20, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): August 31, 2026
• Study Completion (Estimated): August 31, 2026
• Last Updated: December 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)